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Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Pilot Phase II Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

NCT06234748•University of Michigan Rogel Cancer Center

Summary

This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have pathologically confirmed, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
•AJCC 8 Stage III (cT4 or N3)
•ECOG 0-1 performance status within two weeks of enrollment
•Pre-treatment laboratory criteria within four weeks of enrolment: WBC \> 3500/ul, granulocyte \> 1500/ul. Platelet count \> 100,000/ul. Total Bilirubin \< 1.5 X ULN. AST and ALT \< 2.5 X ULN. Estimated Creatinine clearance \>30cc/min
•Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist
•Age \>18
•All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
•Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.

Exclusion Criteria

•Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
•Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
•Patients should have no contraindications to having a contrast enhanced PET scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
•Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
•Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study;

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

December 20, 2023

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

May 13, 2025

Enrollment

ACTUAL participants

Conditions

Oropharynx CancerHPV-Related Carcinoma

Interventions

Radiation

RADIATION

Platinum based chemotherapy

DRUG

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

NCT05639972

HPV-Associated Cervical CarcinomaHPV-Related Carcinoma+15 more

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RECRUITINGPHASE2

Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes

NCT06640283

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Inclusion Criteria

Exclusion Criteria

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer